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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its highest incidence occurs from the second decade of life, affecting significantly the economically active population. Chronic Venous Insufficiency treatment aims to relieve symptoms, treat and prevent complications, prevent recurrences and provide cosmetic satisfaction with minimal side effects. It's current treatment includes some classic postural measures (leg elevation), elastic stockings and bandages compression therapy and possible medication (phlebotonics). The results in the medium and long term are unfavorable, since a large number of patients do not get better or evolves with recurrence of symptoms. Nowadays many, no prospective , not randomized , international studies have shown favorable results with endovascular treatment of obstruction in the iliac vein territory in patients with advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded randomized study is to evaluate the results obtained with endovascular treatment, through the use of angioplasty and stenting in this group of patients when compared with clinical treatment .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Treatment | Active Comparator | Phlebotonics: Aminaftone 75 mg BID Limb elastic compression support (Elastic stockings: Venosan / Elastic Bandages: Atamed) Unna boot dressing |
|
| Iliac vein stenting | Active Comparator | Wallstent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlebotonic | Drug | Aminaftone -- 75 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain on the Pain Visual Analogue Sacale at 6 months | 6 months | |
| Venous ulcer cicatrization at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline Venous Clinical Severity Score at 6 month | 6 months | |
| Change from baseline in SF-36 Quality of Life questionnaire at 6 months | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio H Rossi, PHD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardilogia | São Paulo | São Paulo | 04012-909 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22018502 | Background | Alhalbouni S, Hingorani A, Shiferson A, Gopal K, Jung D, Novak D, Marks N, Ascher E. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012 Feb;26(2):185-9. doi: 10.1016/j.avsg.2011.05.033. Epub 2011 Oct 22. | |
| 19702343 | Background | Kolbel T, Lindh M, Akesson M, Wasselius J, Gottsater A, Ivancev K. Chronic iliac vein occlusion: midterm results of endovascular recanalization. J Endovasc Ther. 2009 Aug;16(4):483-91. doi: 10.1583/09-2719.1. |
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| ID | Term |
|---|---|
| D062108 | May-Thurner Syndrome |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| C016217 | aminaftone |
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Stent | Device | Iliac Vein Stenting |
|
|
| Limb elastic compression support | Procedure | CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages |
|
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| Unna boot dressing | Procedure | CEAP 6 > Unna boot dressing |
|
| Stent integrity at 6 months |
| 6 months |
| Stent position at 6 months | Pelvic X-ray | 6 months |
| Stent patency at 6 months | Stent patency obtained with treated venous segment Duplex Scanning | 6 months |
| 23433816 | Background | Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20. |
| 39968829 | Derived | Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2. |
| 29526687 | Derived | Lorencao de Almeida B, Rossi FH, Guerra de Moraes Rego Sousa A, Kambara AM, Izukawa NM, Beteli CB, Andrade Cavalcante SF, Rodrigues TO, Thorpe PE. Correlation between venous pressure gradients and intravascular ultrasound in the diagnosis of iliac vein compression syndrome. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):492-499. doi: 10.1016/j.jvsv.2017.11.015. Epub 2018 Mar 8. |
| 29292114 | Derived | Rossi FH, Kambara AM, Izukawa NM, Rodrigues TO, Rossi CB, Sousa AG, Metzger PB, Thorpe PE. Randomized double-blinded study comparing medical treatment versus iliac vein stenting in chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):183-191. doi: 10.1016/j.jvsv.2017.11.003. Epub 2017 Dec 29. |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |